Cleared Traditional

K152245 - ONLINE TDM Vancomycin Gen.3

K152245 is an FDA 510(k) clearance for ONLINE TDM Vancomycin Gen.3, manufactured by Roche Diagnostics Operations (Rdo). The device is a Class 2 Chemistry device with product code LEH cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K152245 · Roche Diagnostics Operations (Rdo) · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
151d
Days
Class 2
Risk

K152245 is an FDA 510(k) clearance for the ONLINE TDM Vancomycin Gen.3. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on January 8, 2016 after a review of 151 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3950 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Operations (Rdo) devices

FDA 510(k) Submission Details - K152245

510(k) Number K152245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date January 08, 2016
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEH Device Classification - Class 2, Special Controls

Product Code LEH Radioimmunoassay, Vancomycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LEH Radioimmunoassay, Vancomycin

All 29
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K152245.
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · Siemens Healthcare Diagnostics, Inc. · Aug 2023
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · Siemens Healthcare Diagnostics, Inc. · Apr 2016
ARCHITECT IVANCOMYCIN
K123947 · Biokit, S.A. · Aug 2013
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
K072036 · Biokit, S.A. · Mar 2008
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · Diagnostic Products Corp. · Dec 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · Roche Diagnostics Corp. · May 2006